Product Compliance Lead: GMP, QA & CMC Oversight

University of California, San Francisco; San Francisco (CA); On-site; USD 150,000 - 200,000; Full time

Job summary

University of California, San Francisco (UCSF) in San Francisco seeks a Product Compliance Professional to provide strategic oversight of contract manufacturing organizations (CMOs) supporting a complex, multi-site adaptive platform trial. You will lead cGMP compliance, QA, and CMC regulatory oversight on behalf of UCSF.

The role requires coordinating review of CMO deliverables, ensuring regulatory and contractual standards, and guiding risk management and resolution of manufacturing and quality

Qualifications

• Bachelor’s degree in related areas.
• 5 years of related experience.
• Demonstrated self-discipline and independent judgment completing highly complex, broadly defined assignments.
• Advanced knowledge and ability to apply all relevant Federal, state, and university regulations policies, and federal guidance documents.
• Advanced knowledge of quantitative and qualitative research design, scientific research concepts and terminology.
• Strong scientific knowledge in areas like analytical development and process development.
• Excellent project management skills, including planning, execution, and risk management.
• Proficiency in communicating complex scientific data to technical and non-technical audiences.
• Deep understanding of regulatory requirements and GMP principles.
• Strong proficiency in public speaking, and writing.

Skills

5 years of related experience

Regulatory GMP

Project management

Scientific data communication

Public speaking

Written communication

Education

Bachelor’s degree in related areas

Master's degree or PhD in related area

Job description

University of California, San Francisco (UCSF) in San Francisco seeks a Product Compliance Professional to provide strategic oversight of contract manufacturing organizations (CMOs) supporting a complex, multi-site adaptive platform trial. You will lead cGMP compliance, QA, and CMC regulatory oversight on behalf of UCSF.

The role requires coordinating review of CMO deliverables, ensuring regulatory and contractual standards, and guiding risk management and resolution of manufacturing and quality